NXT Post-Market Clinical Follow-up

Last updated: February 24, 2025
Sponsor: Laborie Medical Technologies Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Incontinence

Enuresis

Genitourinary Prolapse

Treatment

Urodynamic procedure

Clinical Study ID

NCT06336304
NXTPMCF-01
  • All Genders

Study Summary

NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients medically indicated for urodynamic study

  • Patient or legally authorized representative provides written authorization and/orconsent per institution and geographical requirements

Exclusion

Exclusion Criteria:

  • Patients or legally authorized representative with cognitive or psychiatriccondition that interferes with or precludes direct and accurate communicationregarding the study, giving informed consent or ability to complete the patientquestionnaire

  • Patients with confirmed active bladder infections (not including patients withasymptotic bacteria)

  • Pregnant women

  • Patients with recent (less than 2 weeks) pelvic floor surgery

  • Requires use of suprapubic catheter

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: Urodynamic procedure
Phase:
Study Start date:
June 18, 2024
Estimated Completion Date:
December 31, 2025

Study Description

The primary objective of this study is to confirm the safety and performance of NXT urodynamic system for the intended patient populations, medically indicated for urodynamic study.

Connect with a study center

  • Chesapeake Urology Hanover

    Hanover, Maryland 21076
    United States

    Active - Recruiting

  • Chesapeake Urology Owing Mills

    Owing Mills, Maryland 21117
    United States

    Active - Recruiting

  • Chesapeake Urology Owing Mills

    Owings Mills, Maryland 21117
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43212
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

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